MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback

NCT03820024 | Completed Results

• 1 other identifier: LCCC 1614
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Overweight and obese endometrial cancer (EC) survivors at the University of North Carolina (UNC) at Chapel Hill will be approached for tailored feedback fitness intervention. The investigators plan to enroll 36 women (18 in each arm) to evaluate if receipt of weekly tailored feedback messages can improve physical activity in EC survivors. It is hypothesized that women receiving the feedback message intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-intervention arm.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention

  Steps recorded on a fitness tracker at week 1 and week 13

  13 weeks

Study Arms (2)

Tailored Feedback Messages

EXPERIMENTAL

Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period.

Behavioral: Tailored Feedback Messages

No Messages

NO INTERVENTION

No feedback messages

Interventions

Tailored Feedback Messages BEHAVIORAL

Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period.

Tailored Feedback Messages

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be over the age of 18 years
• Have a confirmed diagnosis of endometrial cancer and have completed therapy (surgery, chemotherapy or radiation) within the past 6 months
• Have no current evidence of endometrial cancer
• Have a BMI 25 kg/m2 or greater
• Have approval from their treating physician to engage in moderate-intensity physical activity.
• Have a smart phone with Bluetooth capabilities turned on
• Have access to email

You may not qualify if:

• Are currently undergoing treatment for their cancer
• Are unable to read a sample message aloud
• Do not have a computer or smart phone with Bluetooth capabilities
• Are pregnant
• Have a history of angina or palpitations with exertion
• Have a history of uncontrolled pulmonary disease (COPD or asthma)
• Have one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Leslie Clark
• Organization: UNC Lineberger

leslie_Clark@med.unc.edu

919-966-5996

Study Officials

• Leslie Clark, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: January 29, 2019
• Study Start: September 28, 2018
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2020
• Last Updated: July 29, 2021
• Results First Posted: July 29, 2021

Record last verified: 2021-07

Locations

US (1)